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On December 29, Boton shares rose more than 5%, and individual stocks such as Zhaoyan New Drug, Jiuzhou Pharmaceutical, WuXi AppTec, and Kanglong Chemical also rose significantly
.
On the whole, the market continues to be optimistic about the innovative drug sector, and innovative drug ETFs have net inflows for 5 consecutive trading days
.
Behind this phenomenon, the innovative drug industry is supported by policies, and the overall development trend of the industry is positive
.
Recently, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for Clinical Pharmacology of Innovative Drugs" (hereinafter referred to as "Guiding Principles").
The document covers the introduction, the purpose and role of clinical pharmacology of innovative drugs, and clinical pharmacology.
The overall plan of the research, research content and research timing, research methods, overall considerations of research design, basic considerations of innovative chemical drugs and innovative biological products, regulatory considerations, acronyms and meanings, and references include 10 sections, aiming to Provide suggestions for key issues such as the research content, research timing, and overall design of clinical pharmacology research in the development of innovative drugs
.
Not long ago, the Center for Drug Evaluation also organized the formulation of "Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products (Trial)" and "Technical Guidelines for Non-clinical Research of Gene Modified Cell Therapy Products (Trial)", aiming to standardize domestic gene therapy Product non-clinical research and evaluation, guide the healthy development of the industry, and improve the efficiency of enterprise research and development.
These guidelines are applicable to genetically modified cell therapy products
.
On December 7th, the Center for Drug Evaluation of the State Food and Drug Administration issued a notice on the public solicitation of "Technical Guidelines for the Clinical Evaluation of Intravenous Anesthetics
.
" The notice shows that in order to improve the efficiency of the research and development of such drugs and standardize the design of clinical trials, the Center for Drug Evaluation has organized and written the "Technical Guidelines for Clinical Evaluation of Intravenous Anesthetics" and formed a draft for comments.
The deadline for comments is 2022.
On the 6th
.
In addition, on November 19, CDE issued the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines", striving to resolve the explosive clinical trials of innovative drugs that are trapped in homogenization, and delayed clinical trial efficiency.
R&D issues
.
It can be seen that a series of favorable policies will be introduced intensively at the end of the year, which will promote the better development of China's innovative medicine industry
.
At present, the innovative medicine sector has also attracted great attention from the industry
.
For example, Zheshang Securities stated that the CDE New Deal puts forward higher requirements for innovation and highlights the value of CXO
.
In the past, the target-following strategy has become ineffective.
Only the innovation of the source is true innovation.
CXO companies continue to track and accumulate cutting-edge technologies for new drug research and development, and their innovation capabilities are stronger than most pharmaceutical companies.
CXO leading companies are innovative in medicine.
The value of is more prominent
.
It is also pointed out in the industry that since 2015, policies such as drug review reform, MAH, priority review and approval, and medical insurance payment policies have gradually improved the accessibility of innovative drugs
.
In this regard, it is recommended to pay attention to transitional and innovative companies with low valuations, stable profitability, and top R&D.
At the same time, it is recommended that investors pay attention to FIC-type R&D companies with high R&D investment and strong innovation capabilities
.
CITIC Securities said that it continues to be optimistic about the internationalization of leading innovative pharmaceutical companies.
At present, leading companies have begun to establish global R&D and clinical teams.
It is also an important path to establish strategic cooperation with large multinational pharmaceutical companies
.
2022 is expected to be an important year for Chinese innovative drugs to be launched overseas
.
.
On the whole, the market continues to be optimistic about the innovative drug sector, and innovative drug ETFs have net inflows for 5 consecutive trading days
.
Behind this phenomenon, the innovative drug industry is supported by policies, and the overall development trend of the industry is positive
.
Recently, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for Clinical Pharmacology of Innovative Drugs" (hereinafter referred to as "Guiding Principles").
The document covers the introduction, the purpose and role of clinical pharmacology of innovative drugs, and clinical pharmacology.
The overall plan of the research, research content and research timing, research methods, overall considerations of research design, basic considerations of innovative chemical drugs and innovative biological products, regulatory considerations, acronyms and meanings, and references include 10 sections, aiming to Provide suggestions for key issues such as the research content, research timing, and overall design of clinical pharmacology research in the development of innovative drugs
.
Not long ago, the Center for Drug Evaluation also organized the formulation of "Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products (Trial)" and "Technical Guidelines for Non-clinical Research of Gene Modified Cell Therapy Products (Trial)", aiming to standardize domestic gene therapy Product non-clinical research and evaluation, guide the healthy development of the industry, and improve the efficiency of enterprise research and development.
These guidelines are applicable to genetically modified cell therapy products
.
On December 7th, the Center for Drug Evaluation of the State Food and Drug Administration issued a notice on the public solicitation of "Technical Guidelines for the Clinical Evaluation of Intravenous Anesthetics
.
" The notice shows that in order to improve the efficiency of the research and development of such drugs and standardize the design of clinical trials, the Center for Drug Evaluation has organized and written the "Technical Guidelines for Clinical Evaluation of Intravenous Anesthetics" and formed a draft for comments.
The deadline for comments is 2022.
On the 6th
.
In addition, on November 19, CDE issued the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines", striving to resolve the explosive clinical trials of innovative drugs that are trapped in homogenization, and delayed clinical trial efficiency.
R&D issues
.
It can be seen that a series of favorable policies will be introduced intensively at the end of the year, which will promote the better development of China's innovative medicine industry
.
At present, the innovative medicine sector has also attracted great attention from the industry
.
For example, Zheshang Securities stated that the CDE New Deal puts forward higher requirements for innovation and highlights the value of CXO
.
In the past, the target-following strategy has become ineffective.
Only the innovation of the source is true innovation.
CXO companies continue to track and accumulate cutting-edge technologies for new drug research and development, and their innovation capabilities are stronger than most pharmaceutical companies.
CXO leading companies are innovative in medicine.
The value of is more prominent
.
It is also pointed out in the industry that since 2015, policies such as drug review reform, MAH, priority review and approval, and medical insurance payment policies have gradually improved the accessibility of innovative drugs
.
In this regard, it is recommended to pay attention to transitional and innovative companies with low valuations, stable profitability, and top R&D.
At the same time, it is recommended that investors pay attention to FIC-type R&D companies with high R&D investment and strong innovation capabilities
.
CITIC Securities said that it continues to be optimistic about the internationalization of leading innovative pharmaceutical companies.
At present, leading companies have begun to establish global R&D and clinical teams.
It is also an important path to establish strategic cooperation with large multinational pharmaceutical companies
.
2022 is expected to be an important year for Chinese innovative drugs to be launched overseas
.
